Celiac Plexus Radiosurgery for Pain Management

Sheba Medical Center

Status and phase

Unknown

Phase 2

Conditions

Digestive System Neoplasms

Treatments

Radiation: Celiac Plexus Radiosurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT02356406

SHEBA-14-1630-DH-CTIL

Details and patient eligibility

About

This prospective study evaluates celiac plexus radiosurgery for pain control in patients with upper abdominal malignancies.

Full description

This study aims as primary objective to evaluate short and long term pain relief following the administration of radiosurgery to the celiac plexus in patients with upper abdominal cancer. As secondary objectives it will describe acute and late side effects and quality of life measures of patients undergoing the treatment.

The study has a prospective, single arm design. It will be composed from an initial run-in safety assessment that will include 6 patients and then continue as a phase II trial. All eligible patients will receive the same protocol of celiac plexus radiosurgery and will be evaluated before, during and following this treatment.

The treatment duration is one and a half weeks (5 fractions delivered every other weekday).

Enrollment

52 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with upper abdominal cancer (pancreatic/gastric/colon/hepato-biliary cancer) with typical retroperitoneal pain syndrome (somatic pain that radiates from the upper abdomen to the back) thought to be secondary to celiac plexus involvement, directly or indirectly, and have high level of pain despite opioids usage (NRS >4). Patients with other cancer types metastatic to the celiac lymph nodes will also be eligible
Recent abdominal imaging (CT, PET or MRI) should be at most 2 months old.
Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation and renewed at least 1 week following radiation. Following gemcitabine 2 weeks are required between final dose and commencement of radiation
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Exclusion criteria

Patients under 18 years of age
Patients who are well balanced in terms of pain control
Patients with life expectancy <8 weeks
Patients with ECOG (Eastern cooperative oncology group) performance status 4
Any concurrent chemotherapy or biologic treatment is prohibited during 1 week before until 1 week following radiotherapy
Special populations: pregnant women, prisoners, patients with major psychiatric illnesses
Previous radiotherapy to upper abdomen
Conditions associated with increased side effects to radiotherapy (IBD (inflammatory bowel disease) for example)